Diese Abhandlung untersucht die Frage, ob internationale Richtlinien für die Gentechnologie, insbesondere im Hinblick auf "genetische Verbesserungen" , wünschenswert und machbar erscheinen. Es wird die Auffassung vertreten, daß die Forderung nach solchen internationalen Richtlinien sich unüberwindlichen praktischen Hindernissen gegenübersieht. Den Hintergrund für diese Auffassung bilden die Ambivalenz des Richtlinienkonzepts, das Fehlen einer Autorität, die solche Richtlinien in Kraft setzen könnte, mangelnder Konsens über zentrale Normen oder Werte, die in die Richtlinien einbezogen werden könnten, der Widerstand sowohl von Seiten der Wissenschaft (...) als auch der privaten Wirtschaft gegen solche Richtlinien und schließlich die öffentliche Forderung nach der Einführung von Methoden "genetischer Verbesserung". Die Forschung über Methoden "genetischer Verbesserung" hat schon begonnen und wird sich ohne Zweifel fortsetzen. Es wird daher in diesem Beitrag vorgeschlagen, daß öffentliche Mittel zur Unterstützung der Forschung über "genetische Verbesserung" zur Verfügung gestellt werden, um sicher zu stellen, daß Forschung dieser Art angemessene vorhergehende Begutachtung und andauernde Überwachung erfährt. Öffentlichkeit, Vorausschau und Kritik können uns helfen, vom Mißbrauch des Menschen als Forschungsobjekt und rücksichtslosem Forscherdrang weg und hin zu akzeptablen Formen der "genetischen Verbesserung" zu kommen. This essay explores whether international guidelines in genetics, specifically regarding genetic enhancement, are desirable and feasible. It is argued that the quest for international guidelines faces insuperable practical obstacles. These include the ambiguity of the concept of guidelines, no authoritative body to issue guidelines, lack of consensus about substantive norms or values to be incorporated into guidelines, resistance from the scientific as well as the private business sector to guidelines, and public demand for genetic enhancement. Genetic enhancement research has already begun and will no doubt continue. It is proposed that public funding for genetic enhancement research be provided to ensure that such research receives adequate prior review and continual monitoring. Publicity, oversight, and critique can help steer us away from abuses of human research subjects and reckless science toward acceptable forms of genetic enhancement. (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to (...) dying ICU patients and how palliative care should be distinguished from euthanasia. Participants were drawn from 3 panels: 1) Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs (N = 9); 2) Deputy chief provincial coroners (N = 5); 3) Validation panel of Intensivists attending the Canadian Critical Care Trials Group meeting (N = 12). Results After three Delphi rounds, consensus was achieved on 16 statements encompassing the role of palliative care in the intensive care unit, the management of pain and suffering, current areas of controversy, and ways of improving palliative care in the ICU. Conclusion Consensus guidelines were developed to guide the administration of analgesics and sedatives to dying ICU patients and to help distinguish palliative care from euthanasia. (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Covid‐19 confronts us with tragic choices, in which every option is unacceptable. On the New York State Task Force on Life and the Law, I worked on guidelines for such situations. We did not envision the scale or character of Covid‐19. To minimize fear that the decisions made in these situations might be unfair, we all must know what guidelines or mandates inform them. Only with transparency about how decisions will be made, by whom, and according to what (...) requirements can we have confidence that fairness prevails. We now face many related questions about process, goals, leadership, and trust. For example, how might ethical guidelines evolve as scientific understanding advances? Should guidelines vary with different venues? And if, as I have argued, judgment is necessary even with the best of guidelines, how can we prepare clinicians to make good judgments? Are there implications for better training of personnel in nonemergency times for what they might face in the worst of times? (shrink)

Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the process of (...) involvement. Twenty‐two guidelines published between 2006 and 2019 were analyzed iteratively. The analysis focuses on values which are emphasized in the guidelines on the distribution of entities, knowledge, and tasks between users and researchers. The analysis indicates that users and researchers are constructed differently; researchers are mainly constructed as responsible initiators and caretakers, while users are constructed as powerless and vulnerable. The guidelines portray the collaboration process as harmonious and assume a normative perspective. In doing so, challenges described in the literature related to power imbalances are not addressed. Based on these findings, we ask if these guidelines might function to maintain existing power imbalances between users and researchers. (shrink)

Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.

McGovern, Kevin This article explores the new National Statement on Ethical Conduct in Human Research.

The guidelines of _Scientia et Fides_ can be found on: https://www.chicagomanualofstyle.org/tools_citationguide/citation-guide-2.html or https://apcz.umk.pl/SetF/about/submissions.

For the book that forms the basis for your debate, you’ve either been assigned to defend the thesis of the lead article or its antithesis. The thesis and antithesis are one another’s logical opposites – their contradictions. Consult the course webpage area to read the precise proposition you’re responsible for defending.

Reuse of elements from existing ontologies in the construction of new ontologies is a foundational principle in ontological design. It offers the benefits, among others, of consistency and interoperability between such knowledge structures as well as sharing resources. Reuse is widely found within important collections of established ontologies, such as BioPortal and the OBO Foundry. However, reuse comes with its own potential problems involving ontological commitment, granularity, and ambiguity. Guidelines are proposed to aid ontology developers and curators in their (...) prospective reuse of content. These guidelines have been gleaned over years of practice in the ontology field. The guidelines are couched in experiential reports on designing and curating particular ontologies (e.g., EXACT and EXACT2) and using generally accepted approaches (e.g., MIREOT) in doing so. Various software tools to assist in ontology reuse are surveyed and discussed. (shrink)

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...) conduct in research.There are a number of fairly specific rules, guidelines, or commonly accepted operating principles that have evolved for the ethical conduct of science. In order to discuss this code of ethics, this paper is divided into sections dealing with specific areas of scientific ethics. These areas are: data collection and storage, ownership of data, confidentiality, communication, authorship, collaboration, the peer review system, and rules of dealing with ethical complaints. Illustrative case histories are presented to provide examples of the type of ethical dispute or problem being discussed. If scientific trainees learn the accepted rules of behavior that govern the conduct of science, ethical problems that arise out of ignorance, misunderstanding, or poor communication can be avoided. (shrink)

Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...) against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made. (shrink)

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since (...) most of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

Background Teaching ethical competencies is an essential component of professional and postgraduate curricula. Developing practical–ethical problem-solving competencies as well as appraising program-specific studies and related research ethics are topics typically addressed. However, assessment of these ethical competencies poses a challenge. Written or oral assessment formats addressing relevant learning objectives is mainly limited to knowledge testing alone, often not capturing relevant skills or attitudes pertinent to those competencies. Aim During the reaccreditation of the masters of science program in Nursing Science at (...) Witten/Herdecke University, this challenge was addressed by implementation of an innovative examination format for postgraduate education. Procedure For the module “Ethics in nursing practice and research” a format based on the Objective Structured Clinical Examination format was developed. This assessment method incorporates evaluation of acquired skills and attitudes of nursing students. Conclusion The article demonstrates development and adaption of the OSCE format for this purpose. (shrink)

This article critically looks at the challenges that are incumbent in the deployment of married soldiers who work for the South African National Defence Force. The SANDF previously deployed soldiers outside the borders of South Africa for a period of 6 months or less. But currently, the SANDF has a deployment period of 12 months. This period is twice that of the earlier period, which means that soldiers and their families have to spend 12 months apart from one another. This (...) has an adverse effect on the marriages of soldiers and makes the SANDF appear as an uncaring institute because its military operations tend to impact family lives. Using a qualitative research approach, this article explores the emic experiences of married soldiers who were deployed, and concludes by suggesting some pastoral guidelines that may prove useful for a multi-professional team handling the issues of deployment. (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are (...) nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (shrink)

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. (...) This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, (...) assent and dissent to assess the individual’s judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis. (shrink)

Not only in Lithuania, but also in the other countries, there is a growing tendency among young people to choose a legal education. Law is a professional sphere of immense depth and breadth and it is evident that during several years in a school of higher education, designed to grant legal knowledge and skills, it is impossible to convey all aspects and nuances of the law. Legal education in a higher school is only the beginning of a lawyer’s education, while (...) on the other hand it provides a unifying experience among practising lawyers. Consequently, university law schools preparing lawyers certainly provide an important contribution to the creation of a legal state, while providing skills, modelling values and shaping attitudes for future judges, state officials, prosecutors, attorneys and other persons responsible for the implementation of legal mechanisms necessary for the proper functioning of the state. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work (...) done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.

In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an (...) end the voluntary moratorium that the National Academy of Sciences had instituted several months earlier. They also served to illustrate that the scientific community was capable of self-governance, thereby securing public trust and persuading Congress not to institute legislative restrictions. Finally, they underscored the importance of weighing unforeseen risks inherent in some research against potential benefits that may arise from these same endeavors. (shrink)

The paper develops value based management guidelines from the famous Indian treatise on management, Kautilya's Arthashastra. Guidelines are given for individual components of a total framework in detail, which include guidelines for organizational philosophy, value based leadership, internal corporate culture, accomplishment of corporate purpose and feedback from stakeholders.

Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals (...) who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions). (shrink)

The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages (...) will also be presented and critically discussed. Second, I will show that we need to distinguish between three kinds of conflict that can exist for ethical guidelines used in the moral assessment of AI. This section will be followed by a critical discussion of different answers to the question of how to handle what we shall call internal and external values conflicts. Finally, I will wrap up with a critical discussion of three different strategies to resolve what is called a ‘genuine value conflict’. These strategies are: the ‘accepting the existence of irresolvable conflict’ view, the ranking view, and value monism. This article defends the ‘accepting the existence of irresolvable conflict’ view. It also argues that even though the ranking view and value monism, from a merely theoretical point of view, are better equipped to solve genuine value conflicts among values in ethical guidelines for artificial intelligence, this is not the case in real-life decision-making. Keywords: AI; ethical guidelines; algorithm-based sentencing; value conflicts. (shrink)

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to (...) an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (shrink)

This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the “social sciences versus bioethics” debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences within a principles-based framework for clinical (...) ethics. This paper introduces the curriculum and provides guidelines for how to teach cross-cultural clinical ethics. The learning points that are introduced emphasize culture in its relation to power and underscore the importance of viewing both biomedicine and bioethics as culturally constructed. (shrink)

The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations’ guidelines and ELSI scholarship to develop emerging concerns (...) illuminated by current experience. Four ethical themes characterized previous literature: quality of care and the doctor–patient relationship, access, consent, and privacy. More attention is needed to these and to expanding the scope of ethical analysis to include health information technologies. An applied ethics approach to ELSI would addresses context-specific issues and the relationships between people and technologies, and facilitate effective and ethical institutionalization of telehealth and other health information technologies. (shrink)

This article shows how funding research on Alzheimer's disease became a priority for the British Medical Research Council in the late 1970s and 1980s, thanks to work that isolated new pathological and biochemical markers, and showed that the disease affected a significant proportion of the elderly population. In contrast to histories that focus on the emergence of new and competing theories of disease causation in this period, I argue that concerns over the use of different assessment methods ensured the MRC's (...) immediate priority was standardising the ways in which researchers identified and recorded symptoms of Alzheimer's disease in potential research subjects. I detail how the rationale behind the development of standard assessment guidelines was less about arriving at a firm diagnosis and more about facilitating research by generating data that could be easily compared across the disciplines and sites that constitute modern biomedicine. Drawing on criticism of specific tests in the MRC's guidelines, which some psychiatrists argued were "middle class biased", I also show that debates over standardisation did not simply reflect concerns specific to the fields or areas of research that the MRC sought to govern. Questions about the validity of standard assessment guidelines for Alzheimer's disease embodied broader concerns about education and social class, which ensured that distinguishing normal from pathological in old age remained a contested and historically contingent process. (shrink)

This book is an examination of the literary and philosophical writings of Sartre, what he says about Evil and how to fight it, from which the authors evolve guidelines for applying Sartre's writings to the contemporary world.

Outcomes research in healthcare has been a topic much addressed in recent years. Efforts in this direction have been supplemented by work in the areas of guidelines for clinical practice and computer-interpretable workflow and careflow models.In what follows we present the outlines of a framework for understanding the relations between organizations, guidelines, individual patients and patient-related functions. The derived framework provides a means to extract the knowledge contained in the guideline text at different granularities, in ways that can (...) help us to assign tasks within the healthcare organization and to assess clinical performance in realizing the guideline. It does this in a way that preserves the flexibility of the organization in the adoption of the guidelines. (shrink)